NIVESTYM- filgrastim-aafi injection, solution 
Pfizer Laboratories Div Pfizer Inc

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Instructions for Use
NIVESTYM (Neye-ves-tim)
(filgrastim-aafi)
injection
Single-Dose Prefilled Syringe

Important

Read the Patient Information for important information you need to know about NIVESTYM before using this Instructions for Use.

Before you use a NIVESTYM prefilled syringe, read this important information.

Storing your prefilled syringe
Using your prefilled syringe

Call your healthcare provider if you have any questions.

About the NIVESTYM prefilled syringe

NIVESTYM prefilled syringe parts (see Figure A).

NIVESTYM 300 mcg/0.5mL prefilled syringe is shown as an example.

Figure A

Figure A

What you need for your injection

Included in the carton:

Not included in the carton (see Figure B)

Figure C shows a needle guard that has not yet been activated. The prefilled syringe is ready for use. This is what the prefilled syringe looks like before use.

Figure C

Figure C

Figure D shows a needle guard that has been activated. This is what the prefilled syringe looks like after use.

Figure D

Figure D
Preparing the NIVESTYM prefilled syringe
Step 1:Find a clean, well-lit flat work surface.
Step 2:Take the carton containing the NIVESTYM prefilled syringe out of the refrigerator and leave it unopened on your work surface for at least 30 minutes so that it reaches room temperature. Put the original carton with any unused prefilled syringes back in the refrigerator.
  • Do not shake the prefilled syringe.
  • Do not leave the prefilled syringe in direct sunlight.
Step 3:Wash your hands with soap and water.
Step 4:Remove the prefilled syringe from the carton. Check to make sure that the needle guard is covering the barrel of the prefilled syringe. Do not push the needle guard over the needle cover before the injection. This may activate or lock the needle guard. See Figure C above that shows how the prefilled syringe looks before use.
If the needle guard is covering the needle that means it has been activated. See Figure D above that shows how the prefilled syringe looks after use. Do not use the NIVESTYM prefilled syringe. Get another prefilled syringe that has not been activated and is ready to use.
Step 5:Check the expiration date on the NIVESTYM prefilled syringe. Do not use the NIVESTYM prefilled syringe if the expiration date has passed.
Step 6:Inspect the medicine and prefilled syringe. Turn the prefilled syringe so you can see the medicine and markings in the window. Look through the window on the NIVESTYM prefilled syringe. Make sure the medicine in the prefilled syringe is clear and colorless.
  • Do not use the NIVESTYM prefilled syringe if:
    • The medicine is cloudy or discolored or contains flakes or particles.
    • Any part of the prefilled syringe appears cracked or broken.
    • The prefilled syringe has been dropped.
    • The needle cover is missing or not securely attached.
    • The expiration date printed on the label has passed.
  • In all cases, use a new prefilled syringe and call your healthcare provider.
Step 7:Choose the injection site
  • When giving your injections, follow your healthcare provider's instructions about changing the site for each injection.
  • Areas of your body that you may use as injection sites include (See Figure E):
    • front of your thigh
    • stomach area (abdomen), except for a 2-inch area around your navel (belly button)
    • outer upper outer arms, only if a caregiver is giving you the injection
    • upper outer area of your buttocks, only if a caregiver is giving you the injection

      Figure E

      Figure E
    • Choose a different site for each injection of NIVESTYM.
    • Do not inject into areas where the skin is tender, bruised, red, or hard. Avoid injecting into areas with scars or stretch marks.
Step 8: Clean your injection site with an alcohol wipe. See Figure F.
  • Let your skin dry.
  • Do not touch this area again before injecting.

    Figure F

    Figure F
Step 9: Hold the prefilled syringe by the needle guard with the needle cover pointing up. Carefully pull the needle cover straight off and away from your body. Throw away the needle cover. Do not recap the needle. See Figure G.
Figure G

Figure G

Your healthcare provider has prescribed either a "full" syringe dose or a "partial" syringe dose.

Partial dosing
Step 10:Point the needle up and tap gently until the air rises to the top. See Figure H.
Figure H

Figure H

Step 11:Holding the prefilled syringe as shown, slowly push up on the plunger rod to push out the extra air and medicine until the end of the conical base (edge) of the plunger stopper lines up with the syringe marking for your prescribed dose. See Figure I for an example of a dose of 0.3 mL. Your dose may be different than the example shown.
Be careful not to activate the needle guard before use. Do not use a NIVESTYM prefilled syringe that has been activated.
Check again to make sure the correct dose of NIVESTYM is in the prefilled syringe.
Figure I

Figure I

Administering the NIVESTYM prefilled syringe
Step 12:With one hand, gently pinch a fold of skin at the injection site. Hold the pinch. See Figure J.
Figure J

Figure J

Step 13:With your other hand, hold the prefilled syringe like you would hold a pencil. Use a quick "dart-like" motion to insert the needle at a 45 to 90 degree angle into the skin as shown. See Figure K.

Figure K

Figure K
Step 14:Using slow and constant pressure, press down on the plunger rod as far as it will go. Keep the plunger rod fully pressed down while you hold the prefilled syringe in place for 5 seconds. See Figure L.
Figure L

Figure L

Step 15:Keep the plunger rod fully pressed down while you carefully pull the needle straight out from the injection site. See Figure M.
Figure M

Figure M

Step 16: As you let go of the plunger rod, the needle guard will automatically slide over the needle until the needle is completely covered and the needle guard locks into place. Do not recap the needle. See Figure N.
Figure N

Figure N

Step 17:There may be a small amount of blood at the injection site. You can press a cotton ball or gauze over the injection site and hold it for 10 seconds. Do not rub the injection site. You may cover the injection site with a small adhesive bandage, if needed. See Figure O.
Figure O

Figure O

Step 18:Throw away (dispose of) the syringe as instructed by your healthcare provider or by following the instructions below. See Figure P.
Figure P

Figure P

Disposing of (throw away) used NIVESTYM prefilled syringes

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Manufactured by:
Hospira, Inc.,
a Pfizer Company
Lake Forest, IL 60045 USA
US License No. 1974

Distributed by Pfizer Labs,
division of Pfizer Inc.,
New York, NY 10017 USA

Logo

LAB-0938-3.0

For more information go to www.pfizer.com or call 1-800-438-1985.

Revised: November 2021

Instructions for Use NIVESTYM
(Neye-ves-tim)
(filgrastim-aafi)
injection
Single-Dose Vial

Important

Read the Patient Information for important information you need to know about NIVESTYM before using these Instructions for Use.

Before you use a NIVESTYM vial, read this important information:

Storing your NIVESTYM vial

Keep NIVESTYM and all medicines out of the reach of children.

Using your vial

Call your healthcare provider if you have any questions.

Step 1: Prepare

A
Remove the vial from the refrigerator.
Find a clean, well-lit, flat work surface. Place the vial on your clean work surface for 30 minutes and allow it to reach room temperature before you give an injection.
  • Do not try to warm the vial by using a heat source such as hot water or microwave.
  • Do not leave the vial in direct sunlight.
  • Do not shake the vial.
  • Use the vial only 1 time.
B
Inspect the vial.
Make sure the medicine in the vial is clear and colorless.
  • Do not use the vial if:
    • The medicine is cloudy or discolored or contains flakes or particles.
    • The expiration date printed on the label has passed.
  • In all cases, use a new vial and call your healthcare provider.
C
Gather all materials needed for your injection.
Wash your hands thoroughly with soap and water. On your clean, well-lit, flat work surface, place:
  • 1 Vial
  • 1 Disposable syringe and needle
  • 2 Alcohol wipes
  • 1 Cotton ball or gauze pad
  • 1 Adhesive bandage
  • Sharps disposal container

    Figure

  • Only use the disposable syringes and needles that your healthcare provider prescribes.
  • Only use the syringes and needles 1 time. Throw away (dispose of) any used syringes and needles. See Step 5 Finish, for instructions about how to properly dispose of used syringes and needles.
  • You should only use a syringe that is marked in tenths of milliliters (mL).
  • Your healthcare provider will show you how to measure the correct dose of NIVESTYM. This dose will be measured in milliliters (mL).

Step 2: Get Ready

D
Take the cap off the vial. Clean the rubber stopper with 1 alcohol wipe.
Figure
E
Check the carton containing the needle and syringe. If the carton has been opened or damaged, do not use that needle and syringe. Dispose of (throw away) that needle and syringe in the sharps disposal container.
F
Hold the syringe by the barrel with the needle cap pointing up. Carefully pull the needle cap straight off and away from your body.

Figure


Pull back on the plunger and draw air into the syringe that is the same amount (mL) as the dose of NIVESTYM that your healthcare provider prescribed.

Important: Throw away the needle cap into the sharps disposal container. Do not recap the needle.

G
Keep the vial on the flat work surface and insert the needle straight down through the rubber stopper. Do not insert the needle through the rubber stopper more than 1 time.
H
Push the plunger down and inject all the air from the syringe into the vial of NIVESTYM.
Figure
I
Keep the needle in the vial and turn the vial upside down. Make sure that the NIVESTYM liquid is covering the tip of the needle.
Figure
J
Keep the vial upside down and slowly pull back on the plunger to fill the syringe barrel with NIVESTYM to the correct marking amount (mL) of medicine that matches the dose your healthcare provider prescribed.
K
Keep the needle in the vial and check for air bubbles in the syringe. If there are air bubbles, gently tap the syringe barrel with your finger until the air bubbles rise to the top. Slowly push the plunger up to push the air bubbles out of the syringe.
Figure
L
Keep the tip of the needle in the liquid and again pull the plunger back to the number on the syringe barrel that matches your dose. Check again for air bubbles. The air in the syringe will not hurt you, but too large an air bubble can reduce your dose of NIVESTYM. If there are still air bubbles, repeat the steps above to remove them.
M
Check again to make sure that you have the correct dose in the syringe. It is important that you use the exact dose prescribed by your healthcare provider. Do not remove the needle from the vial. Lay the vial down on its side with the needle still in the vial.

Step 3: Select and Prepare the Injection Site

N
Prepare and clean your injection site.

Figure


You can use:
  • Thigh
  • Stomach area (abdomen), except for a 2-inch area right around your navel (belly button)
  • Upper outer area of your buttocks (only if someone else is giving you the injection)
  • Outer area of upper arm (only if someone else is giving you the injection)
Clean your injection site with a clean alcohol wipe.
  • Let your skin dry.
  • Do not touch this area again before injecting.
  • If you want to use the same injection site, make sure it is not the same spot on the injection site area you used for a previous injection.
  • Do not inject into areas where the skin is tender, bruised, red, or hard. Avoid injecting into areas with scars or stretch marks.

Step 4: Subcutaneous (under the skin) injection

O
Remove the prepared syringe and needle from the vial.
P
Pinch your injection site to create a firm surface.
Figure

Important: Keep skin pinched while injecting.

Q
Hold the pinch. Insert the needle into the skin at a 45 to 90 degree angle.
Figure
R
Using slow and constant pressure, push the plunger until it reaches the bottom.
Figure

When done gently pull the needle out of the injection site at the same 45 to 90 degree angle used to insert it.
Figure

Step 5: Finish

S
Dispose of (throw away) the used needle and syringe.
Figure
  • Put your used needles and syringes in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles, and syringes in your household trash.
  • If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
    • made of a heavy-duty plastic,
    • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
    • upright and stable during use,
    • leak-resistant, and
    • properly labeled to warn of hazardous waste inside the container.
  • When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.
  • Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.
T
Examine the injection site.
If there is blood, press a cotton ball or gauze pad on your injection site. Do not rub the injection site. Apply an adhesive bandage if needed.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Manufactured by:
Hospira, Inc.,
a Pfizer Company
Lake Forest, IL 60045 USA
US License No. 1974

Distributed by Pfizer Labs,
division of Pfizer Inc.,
New York, NY 10017 USA

Logo

LAB-0937-3.0
For more information go to www.pfizer.com or call 1-800-438-1985.

Revised: November 2021

Revised: 11/2021
Document Id: d162e7e0-164c-4099-88e8-db319b60f6b7
Set id: d23ab39c-b6ec-41cf-a529-9dd2852c9d9a
Version: 11
Effective Time: 20211123
 
Pfizer Laboratories Div Pfizer Inc